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Filgrastim

Phase 4FDA approved

HIV Infections | Small molecule | Infectious Disease |Amgen Inc.|Trials Updated: Mar 7, 2014

Filgrastim development status

FDA approval on record Apr 2, 1998 as Neupogen
Approval holderAmgen
ApplicationBLA103353
Highest phase Phase 4 run by Sandoz (NCT01859637)
Phase scored for AMGNPhase 2
Registered trials 78 across 37 sponsors since Aug 2001

Label indication NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment… FDA label

Filgrastim target and mechanism

Molecular targetCSF3R
Target classAgonist
ModalitySmall molecule

Also known as Injection of Filgrastim, of Filgrastim

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials4
Total Enrollment360

FDA Designations

No designations recorded

Filgrastim clinical trials

Filgrastim · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT00114764Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)Myeloid Leukemia
COMPLETED84 Analytics
NCT00002126A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.HIV Infections
COMPLETED250 Analytics
PHASE2COMPLETED
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Myeloid LeukemiaUnlock trial analytics
PHASE2COMPLETED
A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Induction cycle 1
feasibility of administering study therapy to limit skin toxicity
4 weeks
dose-limiting toxicity
4 weeks

Secondary Endpoints

Duration of severe neutropenia during induction chemotherapy
Induction cycle 1
response
14 weeks
time to progression
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
pegfilgrastimEXPERIMENTALPegfilgrastim given once after induction chemotherapy
filgrastimACTIVE_COMPARATORFilgrastim given daily after induction chemotherapy

Interventions

NameTypeDescription
filgrastimDRUGFilgrastim given daily after induction chemotherapy
pegfilgrastimDRUGPegfilgrastim given once after induction chemotherapy
PaclitaxelDRUG1-hour IV infusion once weekly for 12 to 14 weeks
VinorelbineDRUGescalating doses administered intravenously over 6-10 minutes for 12-14 weeks
RadiationRADIATIONRadiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy
Epoetin alfaDRUG -
ZidovudineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion * Histologically confirmed de novo AML as evidenced by absence of an antecedent hematologic disease of \> 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria) * Life expectancy, with treatment, \> 3 months * Age \> 18 y...

Countries:United StatesCanada
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Frequently asked questions about Filgrastim

What is Filgrastim used for?

Filgrastim is being studied in breast cancer, HIV infections, and myeloid leukemia. It has been tested as supportive care alongside chemotherapy and antiretroviral regimens, including in patients with advanced breast cancer, acute myeloid leukemia, and HIV-related cytopenias. It remains an investigational therapy in these settings.

What does Filgrastim target?

Filgrastim targets CSF3R, also known as the granulocyte colony-stimulating factor receptor. It acts as an agonist at this receptor, mimicking the natural G-CSF ligand to stimulate neutrophil production and function. This mechanism underlies its investigation as supportive care in chemotherapy and HIV-related neutropenia.

Who makes Filgrastim?

Filgrastim is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor associated with the clinical development of this agent across the studied indications.

What phase is Filgrastim in?

Filgrastim is in Phase 1 development. It is investigational and has not been approved for the indications studied here. The clinical program includes Phase 1 and Phase 2 trials, all of which are completed, with no active trials currently listed.

What clinical trials is Filgrastim in?

Filgrastim has been evaluated in completed trials including NCT00724386 in advanced breast cancer, NCT00114764 comparing pegfilgrastim with filgrastim in acute myeloid leukemia, NCT00002255 in HIV and AIDS-related complex, and NCT00002126 for prevention of grade 4 neutropenia in HIV infection.

Is Filgrastim the same as Injection of Filgrastim?

Yes, Filgrastim is also known as Injection of Filgrastim. These names refer to the same agent, which is developed by Amgen Inc. (AMGN) and targets CSF3R as an agonist. It is being studied in breast cancer, HIV infections, and myeloid leukemia.